NCT03160742

Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 12 Months – 10 Years
• Healthy volunteers: Not accepted

Summary

The goal of this research study is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).

Detailed description

Central venous pressure (CVP), also known as right atrial pressure (RAp), is a reflection of the right heart filling pressure i.e the preload of the right ventricle. Assessment of the CVP is essential in the management of different clinical situations in children. Invasive CVP monitoring by placement of a CVP catheter either in the internal jugular vein or the subclavian vein is the gold standard way of measuring the CVP both in children and adults. However, placing a CVP catheter in a child can be challenging, time consuming, often requires the child to be sedated and it is not without complications. Being able to reliably measure the CVP noninvasively would be of great benefit for sick children as it may allow diagnoses to be made quickly and help guide treatment. The goal of this proposal is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).

Conditions

• Central Venous Pressure

Interventions

Type	Name	Description
DEVICE	Mespere VENUS 200CVP system	Non-invasive sensor placed on the neck

Timeline

• Start date: 2018-04-25
• Primary completion: 2018-04-25
• Completion: 2018-09-14
• First posted: 2017-05-19
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study